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Completed

NCT Number: NCT05659823

Postoperative Pain After Caesarian Section

To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.

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Key information

About this study

Control group (current analgesia, elective CS) is compared to current analgesia for emergency CS, and guideline recommended analgesia.

Current analgesia for CS:

Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 10-15 ug. Postoperative: Paracetamol 1g x 4, ibuprofen 400 mg x 4 po, oxycodone 10 mg (<70 kg) or 20 mg (>70 kg) x 2 po, additional oxycodone 2,5 mg iv/5 mg po when needed.

Guideline recommended analgesia for CS:

Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 12,5 ug. Spinal morphine 0,05 mg. After delivery of baby: Dexamethasone 8 mg iv, paracetamol 1g iv, parecoxib 40 mg iv.

Postoperative: Paracetamol 1g x 4, ibuprofen 600 mg x 4 po, oxycodone 2,5 mg iv/5 mg po when needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy parturient, term pregnancy, undergoing caesarian section

Exclusion criteria

  • Patient refusal
  • Maternal heart or lung disease (not including mild asthma)
  • Known or suspected obstructive sleep apnoea syndrome
  • Pre-eclampsia
  • Body mass index > 40
  • Indulin-dependent diabetes mellitus
  • Contraindications to ibuprofen, dexamethasone or morphine
  • Chronic pain
  • Neurological disease
  • Drug abuse
  • Age < 18 years
  • American Society of Anesthesiologists (ASA) 3
  • Patients receiving other forms of anaesthesia (epidural or general)

Treatment and study plan

Bupivacaine-fentanyl-morphine elective group

Drug

Guideline recommended analgesia in elective caesarian section.

Bupivacaine-fentanyl elective group

Drug

Current analgesia in elective caesarian section.

Bupivacaine-fentanyl emergency group

Drug

Current analgesia in emergency caesarian section.

Primary outcomes

  1. Postoperative pain at postoperative care unit arrival

    Time frame: Immediately upon arrival at postoperative care unit

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  2. Postoperative pain at 30 minutes

    Time frame: At postoperative care unit 30 minutes after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  3. Postoperative pain at 60 minutes

    Time frame: At postoperative care unit 60 minutes after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  4. Postoperative pain at 90 minutes

    Time frame: At postoperative care unit 90 minutes after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  5. Postoperative pain at 120 minutes

    Time frame: At postoperative care unit 120 minutes after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  6. Postoperative pain at maternity ward arrival

    Time frame: Immediately upon arrival at maternity ward

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  7. Postoperative pain at maternity ward 4 hours after arrival

    Time frame: At maternity ward 4 hours after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  8. Postoperative pain at maternity ward 8 hours after arrival

    Time frame: At maternity ward 8 hours after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  9. Postoperative pain at maternity ward 12 hours after arrival

    Time frame: At maternity ward 12 hours after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  10. Postoperative pain at maternity ward 16 hours after arrival

    Time frame: At maternity ward 16 hours after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

  11. Postoperative pain at maternity ward 20 hours after arrival

    Time frame: At maternity ward 20 hours after arrival

    Postoperative pain during rest and movement measured by numeric rating scale (NRS).

Secondary outcomes

  1. Postoperative nausea and vomiting at postoperative care unit

    Time frame: During stay at postoperative care unit, estimated average 2 hours

    Present (yes/no) during stay at the postoperative care unit

  2. Postoperative nausea and vomiting at maternity ward

    Time frame: During stay at maternity ward, estimated average 22 hours

    Present (yes/no) during stay at the maternity ward

  3. Postoperative pruritus at postoperative care unit

    Time frame: During stay at postoperative care unit, estimated average 2 hours

    Present (yes/no) during stay at the postoperative care unit

  4. Postoperative pruritus at maternity ward

    Time frame: During stay at maternity ward, estimated average 22 hours

    Present (yes/no) during stay at the maternity ward

  5. Postoperative additional oxycodone consumption at postoperative care unit

    Time frame: During stay at postoperative care unit, estimated average 2 hours

    Number of mg of oxycodone administered as additional analgetics

  6. Postoperative additional oxycodone consumption at maternity ward

    Time frame: During stay at maternity ward, estimated average 22 hours

    Number of mg of oxycodone administered as additional analgetics

Sponsors and collaborators

Lead sponsor

Conrad Arnfinn Bjørshol

Other Gov

Registry information

Official study title

Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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